The U.S. Food and Drug Administration (FDA) has granted approval for CLAIRITY BREAST — the first platform of its kind based on imaging that can help predict the risk of breast cancer in women, according to *Health Day*.

CLAIRITY BREAST is designed as a prognostic tool that can predict the five-year risk of developing breast cancer by analyzing subtle image features in standard mammograms, enabling early risk assessment.

The confirmed five-year risk evaluation is then shared with healthcare providers through their existing clinical systems.

“What makes the availability of CLAIRITY BREAST a real breakthrough is that we can now forecast future cancer risk based on changes in breast tissue seen in standard screening — before the cancer actually develops,” said Clairity CEO Jeff Luber. “CLAIRITY BREAST is designed to seamlessly integrate into today’s clinical infrastructure.”

The artificial intelligence model embedded in CLAIRITY BREAST has been rigorously trained using millions of images.

Its effectiveness was validated using over 77,000 mammograms collected from five geographically diverse screening centers. These include both hospital-based and standalone facilities, collectively serving a broad and diverse patient population. Validation was based on comprehensive five-year outcome data.

“Risk-based personalized screening is essential to improving breast cancer outcomes, and AI tools offer us the best opportunity to realize that potential,” said Dr. Robert Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society. “By integrating AI models that assess individual risk, we can better identify women at elevated risk and those who may benefit from supplemental screening methods like MRI — improving early detection and enhancing prevention strategies.”